The EU Personal Protective Equipment (PPE) Regulation (EU) 2016/425 sets uniform requirements for PPE to ensure wearer safety and free market movement within the EU. It applies to all PPE placed on the EU market, whether for professional or private use. Exemptions include PPE for military, law enforcement, and certain private uses against non-extreme weather.

Manufacturers must carry out a risk assessment, design PPE to minimise identified risks, and ensure it meets essential health and safety requirements (EHSRs). Harmonised European Standards (EN) help demonstrate conformity but are voluntary.

PPE is classified into three risk categories:

• Category I: Simple design (e.g., sunglasses, gardening gloves) – self-certified by manufacturer.
• Category II: Intermediate risks – requires EU-type examination by a notified body.
• Category III: Complex PPE (e.g., respiratory equipment, harnesses) – requires EU-type examination and ongoing production quality control.

Each item must be supplied with usage instructions and bear CE marking. A EU Declaration of Conformity must accompany each product. Manufacturers must keep technical documentation for 10 years. Importers/distributors must verify compliance before placing products on the EU market.

Further guidance and details are provided by the European Commission’s PPE sector page and official regulation text via EUR-Lex.